Method for determining fingerprint spectrum of traditional Chinese medicine for treating coronary heart disease

A technology of traditional Chinese medicine preparations and fingerprints, applied in the field of medicine, can solve the problems of insufficient internal quality of traditional Chinese medicine preparations, and achieve the effects of improving neural function defects, good reproducibility, and inhibiting platelet aggregation.

Active Publication Date: 2014-04-30
SHAANXI BUCHANG PHARMA
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  • Abstract
  • Description
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Problems solved by technology

We first applied for the patent of publication number CN1686294A for this Chinese medicine preparation, which discloses the prescription and preparation method of its Chinese medicine preparation for the treatment of coronary heart disease. The quality standard of the preparation only controls the content of salvianolic acid B and tanshinone IIA, which is obviously not enough to control the internal quality of traditional Chinese medicine preparations

Method used

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  • Method for determining fingerprint spectrum of traditional Chinese medicine for treating coronary heart disease
  • Method for determining fingerprint spectrum of traditional Chinese medicine for treating coronary heart disease
  • Method for determining fingerprint spectrum of traditional Chinese medicine for treating coronary heart disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1: Establishment of the fingerprint measurement method of the traditional Chinese medicine preparation of the present invention

[0034] 1.1 Instruments and reagents

[0035] Agilent1260 (quaternary pump G1311B; autosampler G1329B; column thermostat G1316A; diode array detector G4212B; LAB open chromatographic data workstation); electronic analytical balance (model BP211D, d=0.01mg, Germany Sartorius Balance Co., Ltd. ); Ultrasonic cleaner (model: KQ-250DE, Kunshan Ultrasonic Instrument Co., Ltd.); Agilent ZORBAX Extend-C 18 Chromatographic column (250mm×4.6mm, 5μm).

[0036] 1.2 Test drug

[0037] Ten batches of the Chinese medicine preparations of the present invention were produced by Shaanxi Buchang Pharmaceutical Co., Ltd., and the sample numbers of the ten batches were Y 1 , Y 2 , Y 3 , Y 4 , Y 5 , Y 6 , Y 7 , Y 8 , Y 9 , Y 10 , National Medicine Standard Z20020055, is a capsule. Methanol is chromatographically pure (Fisher Reagent Company, USA), water is Wahaha ...

Embodiment 2

[0070] Example 2 Establishment of the fingerprint of the traditional Chinese medicine preparation of the present invention

[0071] 2.1 Preparation of test solution

[0072] Take about 1g of the contents of 10 different batches of traditional Chinese medicine preparations, accurately weigh them, place them in a 100mL conical flask with stopper, add 10mL of 70% methanol, weigh, ultrasonic (100W, 45kHz) for 30min, let cool, and make up with 70% methanol Lost weight, shake well, filter through 0.45μm microporous membrane, and take the filtrate to get it.

[0073] 2.2 Chromatographic conditions:

[0074] Column: Agilent ZORBAX Extend-C18 column (250mm×4.6mm, 5μm); column temperature: 35℃, flow rate: 1.0mL·min -1 , Use methanol as mobile phase A, 0.4% phosphoric acid aqueous solution as mobile phase B, and perform gradient elution according to the volume concentration ratio procedure in Table 5.

[0075] Table 5 Mobile phase gradient elution conditions

[0076]

[0077] Detection wavelength:...

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Abstract

The invention relates to a method for determining fingerprint spectrum of traditional Chinese medicine for treating coronary heart disease. The method comprises the following steps: preparing a test solution, preparing a reference solution, and carrying out gradient elution under the chromatographic conditions that an Agilent ZORBAX Extend C18 chromatographic column is used as a filling agent, a mobile phase A is methanol and a mobile phase B is 0.4% phosphoric acid water solution; determining under conditions that the flow velocity is at 1.0ml/min, the column temperature is at 35 DEG C and the detection wavelength is 230-240nm, thus obtaining the fingerprint spectrum of traditional Chinese medicine. The method has the characteristics of being simple and convenient, good in reproducibility, more in characteristic peaks, accurate and reliable, and the like, and the quality of the traditional Chinese medicine preparation can be controlled effectively by the established fingerprint spectrum.

Description

Technical field [0001] The invention relates to a method for determining the fingerprint of a traditional Chinese medicine preparation for treating coronary heart disease, in particular to a method for determining the effective substance in a traditional Chinese medicine preparation by a high performance liquid chromatography fingerprint method, and belongs to the technical field of medicine. Background technique [0002] Traditional Chinese medicine has a long history in my country. As a material carrier of Chinese medicine for disease prevention and treatment, its inherent quality is directly related to clinical efficacy and safety. For this reason, establishing a quality control system for traditional Chinese medicine preparations that can be accepted by the international pharmaceutical industry is one of the key issues in the development of Chinese medicine. The quality control of traditional Chinese medicine is an important part of the modernization of traditional Chinese me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/86
Inventor 赵超刘峰李晔杨东华龙凯华马久太孙雯黄壮壮吴云生千珂张建
Owner SHAANXI BUCHANG PHARMA
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